F20 F25
Conditions
Interventions
Group 1: amisulpride 400-800 mg/d + olanzapine 10-20 mg/d for 16 weeks
Group 2: amisulpride 400-800 mg/d + Placebo for 16 weeks
Group 3: olanzapine 10-20 mg/d + Placebo for 16 weeks
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with schizophrenia and schizoaffective disorder according to ICD-10; age 18-65 years; Positive and Negative Symptom Scale Total-Score = 70 and two items of the positive symptom subscale =4; voluntary treatment after written informed consent; legal capacity; patients being able and willing to follow study procedures according to the protocol (i.e. sufficient knowledge of German language); exclusion of pregnancy by laboratory test (Beta HCG)
Exclusion criteria
Exclusion criteria: participation in other interventional studies with drugs or medical devices; first episode patients; physical disease that might have effects on the conduct or evaluation of the tria; contraindications to medication according to experts information; oversensitivity to active substance or other component of the drugs used; known clozapin resistance; suicidal ideation; pregnancy or lactation; wish of pregnancy or absence of save contraception; dependency to sponsor or investigator; institutionalization through judicial or regulatory order; oversensitivity to placebo (Mannit/Aerosil)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of the PANSS total score, which shows the efficiency of treatment by reduction of acute positive and negative symptoms, from baseline to treatment week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| - PANSS total score reduction from baseline to week 16. - PANSS total score reduction from baseline to every 2 weeks up to week 16. - PANSS total score reduction from baseline to week 2 as predictor of the change after 8 weeks - change of the clinical condition measured every 2 weeks by CGI from baseline up to week 16. - change of the subjective well-being under therapy measured by the SWN scale between week 0, 8, 16. - Frequency and severity of serious adverse drug reactions | — |
Countries
Germany
Contacts
Public ContactChristian Schmidt-Kraepelin
LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
Outcome results
None listed